Prospective Validation of 3D Dose Metrics as Selection Criteria for Adaptive Radiotherapy in Breast Cancer Patients

March 7, 2019 updated by: Maastricht Radiation Oncology
In a retrospective study the investigators defined quantitative action levels based on dose and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al. Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During radiotherapy, changes in patient anatomy or positioning can result into differences in dose deposition, which is the main factor influencing tumor control or side-effects. Dose-guided radiation therapy is the systematic evaluation of the dose delivery during treatment for an individual patient with the aim to adapt the treatment if needed. Recalculation of the dose during treatment can be performed using the imaging information during treatment. In a retrospective study the investigators defined quantitative action levels based on dose and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al. Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective study.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Maastricht Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

  1. Whole breast irradiation (N=10)
  2. Simultaneous integrated boost (N=10)
  3. Patients with seroma at start radiation treatment (N=10)

Description

Inclusion Criteria:

  • Breast cancer patients
  • Planned for external beam radiation treatment.
  • Whole breast irradiation or Simultaneous integrated boost

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
whole breast irradiation, CBCT imaging at first and last fraction of radiotherapy treatment
Other: CBCT imaging
CBCT imaging at first and last fraction of radiotherapy treatment
group 2
simultaneous integrated boost, CBCT imaging at first and last fraction of radiotherapy treatment
Other: CBCT imaging
CBCT imaging at first and last fraction of radiotherapy treatment
group 3
patients with seroma at start radiation treatment (whole breast irradiation or simultaneous integrated boost), CBCT imaging at first and last fraction of radiotherapy treatment
Other: CBCT imaging
CBCT imaging at first and last fraction of radiotherapy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of quantitative action levels
Time Frame: 3-4 weeks (time between 1st and last fraction of radiotherapy)
Evaluation of DVH parameters on the CBCT of the 1st and last fraction of radiotherapy treatment. Evaluate if the changes during treatment are within the thresholds set by the previous retrospective study; are parameters within predefined criteria yes/no
3-4 weeks (time between 1st and last fraction of radiotherapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Automatic re-delineation
Time Frame: 3-4 weeks (time between 1st and last fraction or radiotherapy)
Evaluation of automatic re-delineation of the target volume against manual re-delineation by a radiotherapy oncologist on the CBCT of the 1st and last fraction of radiotherapy treatment.
3-4 weeks (time between 1st and last fraction or radiotherapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Investigators

  • Principal Investigator: Karolien Verhoeven, PHD, Radiation Oncologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

August 20, 2018

Study Completion (Actual)

August 20, 2018

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0268

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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